US6387377B1ExpiredUtility

Acellular antibordetella vaccine

63
Assignee: PASTEUR INSTITUTPriority: Dec 15, 1994Filed: Dec 15, 1995Granted: May 14, 2002
Est. expiryDec 15, 2014(expired)· nominal 20-yr term from priority
A61P 31/04C07K 14/235A61K 2039/52Y10S435/814C12N 9/88A61K 39/00C12R 2001/01C12N 1/205
63
PatentIndex Score
14
Cited by
52
References
31
Claims

Abstract

The invention relates to an immunogenic composition, characterized in that it comprises an adenyl cyclase-hemolysin (AC-Hly) protein, or an immunogenic portion of this AC-Hly, of a strain of Bordetella chosen from B. Tertussis, B. parapertussis or B. bronchiseptica, and in that it comprises, in addition, a bacterial extract containing the expression products of the vrg genes of a strain of Bordetella chosen from B. pertussis, B. parapertussis or B. bronchiseptica, or a portion of these expression products which is sufficient to induce an immune response in a host to which the extract might be administered.

Claims

exact text as granted — not AI-modified
What is claimed is:  
     
       1. An immunogenic composition comprising 
       (a) an adenyl cyclase-hemolysin (AC-Hly) protein of a strain of Bordetella selected from the group consisting of  B. pertussis, B. parapertussis,  and  B. bronchiseptica,  and  
       (b) a bacterial extract containing the expression products of the vrg genes of a strain of Bordetella selected from the group consisting of  B. pertussis, B. parapertussis,  and  B. bronchiseptica,  or a portion of these expression products, which is sufficient to induce an immune response in a host.  
     
     
       2. The immunogenic composition according to  claim 1 , further comprising one or more adhesins or toxins of Bordetella selected from the group consisting of  B. pertussis, B. parapertussis,  and  B. bronchiseptica,  wherein the adhesin or toxin is selected from the group consisting of filamentous hemagglutinin, the agglutinogens, pertactin, and pertussis toxin. 
     
     
       3. The immunogenic composition according to  claim 1  or  claim 2  comprising the PTX toxin of  B. pertussis,  the AC-Hly toxin of  B. pertussis  and a bacterial extract containing the proteins encoded by the vrg genes of  B. pertussis,  or a portion of these proteins which is sufficient to induce an immune response in a host. 
     
     
       4. The immunogenic composition according to  claim 3 , wherein the AC-Hly toxin of  B. pertussis  is contained in a bacterial extract containing all or part of the virulence factors of the adhesin or toxin group of  B. pertussis.    
     
     
       5. The immunogenic composition according to  claim 3 , wherein the AC-Hly toxin of  B. pertussis  is present in the form of a Vag urea extract. 
     
     
       6. The immunogenic composition according to  claim 1  or  claim 2 , wherein the bacterial extract is a  B. pertussis  Vrg urea extract and wherein the AC-Hly toxin of  B. pertussis  is present in the form of a Vag urea extract. 
     
     
       7. The immunogenic composition according to  claim 1  or  claim 2 , wherein the bacterial extract is a  B. parapertussis  Vrg urea extract and the AC-Hly toxin is from  B. parapertussis.    
     
     
       8. The immunogenic composition according to  claim 7 , wherein the AC-Hly toxin of  B. parapertussis  is contained in a bacterial extract containing all or part of the virulence factors of the adhesin or toxin group of  B. parapertussis.    
     
     
       9. The immunogenic composition according to  claim 7 , wherein the AC-Hly toxin of  B. parapertussis  is present in the form of a Vag urea extract. 
     
     
       10. The immunogenic composition according to  claim 1  or  claim 2 , wherein the bacterial extract is a  B. parapertussis  Vrg urea extract and wherein the AC-Hly toxin of  B. parapertussis  is present in the form of a Vag urea extract. 
     
     
       11. The immunogenic composition according to  claim 1  or  claim 2 , wherein the bacterial extract is a  B. bronchiseptica  Vrg urea extract and the AC-Hly toxin is from  B. bronchiseptica.    
     
     
       12. The immunogenic composition according to  claim 11 , wherein the AC-Hly toxin of  B. bronchiseptica  is contained in a bacterial extract containing all or part of the virulence factors of the adhesin or toxin group of  B. bronchiseptica.    
     
     
       13. The immunogenic composition according to  claim 11 , wherein the AC-Hly toxin of  B. bronchiseptica  is present in the form of a Vag urea extract. 
     
     
       14. The immunogenic composition according to  claim 1  or  claim 2 , wherein the bacterial extract is a  B. bronchiseptica  Vrg urea extract and wherein the AC-Hly toxin of  B. bronchiseptica  is present in the form of a Vag urea extract. 
     
     
       15. The immunogenic composition according to  claim 1  further comprising polypeptide components characteristic of the flagella of  B. bronchiseptica.    
     
     
       16. The immunogenic composition according to  claim 1  or  claim 2 , wherein the AC-Hly toxin is in pure form. 
     
     
       17. The immunogenic composition according to  claim 16 , wherein the toxin is replaced by AC-Hly fragments containing at least one member of the group consisting of the C-terminal portion of the toxin and one internal domain of AC-Hly. 
     
     
       18. The immunogenic composition according to  claim 1  or  claim 2 , wherein the  B. pertussis  strain from which the AC-Hly toxin and the proteins expressed by the vrg genes are obtained, is the strain HAV deposited at the CNCM under No. I-1485. 
     
     
       19. The immunogenic composition according to  claim 1  or  claim 2 , wherein the  B. parapertussis  strain from which the AC-Hly toxin and the proteins expressed by the vrg genes are obtained is the strain No. 1 deposited at the CNCM under No. I-1498. 
     
     
       20. The immunogenic composition according to  claim 1  or  claim 2 , wherein the  B. bronchiseptica  strain from which the AC-Hly toxin and the proteins expressed by the vrg genes are obtained is the strain 973S deposited at the CNCM under No. I-858. 
     
     
       21. A vaccinating composition comprising an immunogenic composition according to  claim 1  or  claim 2 , in combination with a pharmaceutically acceptable vehicle and, where appropriate, an adjuvant. 
     
     
       22. The vaccinating composition according to  claim 21 , wherein the immunogenic composition comprises: 
       (a) a composition comprising a pertussis toxin of  B. pertussis,  an AC-Hly toxin of  B. pertussis,  and a bacterial extract containing the proteins encoded by the vrg genes of  B. pertussis,  or a portion of these proteins, which is sufficient to induce an immune response in a host to which the extract which is administered; and  
       (b) a composition comprising an AC-Hly toxin of  B. parapertussis  and a bacterial extract containing all or part of the proteins encoded by the vrg genes of  B. parapertussis.    
     
     
       23. The vaccinating composition according to  claim 21 , wherein the bacterial extract is a  B. bronchiseptica  Vrg urea extract and the AC-Hly toxin is from  B. bronchiseptica.    
     
     
       24. The vaccinating composition according to  claim 21 , comprising a Vag urea extract of  B. pertussis  and a Vrg urea extract of  B. pertussis.    
     
     
       25. The vaccinating composition according to  claim 21 , comprising a Vag urea extract of  B. parapertussis  and a Vrg urea extract of  B. parapertussis.    
     
     
       26. The vaccinating composition according to  claim 21 , comprising a Vag urea extract of  B. bronchiseptica  and a Vrg urea extract of  B. bronchiseptica.    
     
     
       27. The vaccinating composition according to  claim 21 , comprising a Vag urea extract of  B. pertussis  and a Vrg urea extract of  B. pertussis,  and Vag urea extract of  B. parapertussis.    
     
     
       28. The vaccinating composition according to  claim 27 , further comprising a Vag urea extract of  B. bronchiseptica.    
     
     
       29. The immunogenic composition according to  claim 1  or  claim 2 , wherein the bacterial extract expressing the virulence repression proteins encoded by the vrg genes of a strain of Bordetella chosen from  B. pertussis, B. parapertussis  or  B. bronchiseptica,  or a portion of these proteins which is sufficient to induce an immune response in a host, is replaced, respectively, by a  B. pertussis, B. parapertussis  or  B. bronchiseptica  strain whose bvgS gene is mutated in such a way that the bacterium essentially expresses the vrg genes to the detriment of the vag genes. 
     
     
       30. The vaccinating composition according to  claim 21 , further comprising an inactivated pathogenic agent or a toxin. 
     
     
       31. The immunogenic composition according to  claim 3  further comprising filamentous hemagglutinin and pertactin.

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